CQV 

Commissioning, Qualification, and Validation

PSC is one of the largest providers for Commissioning, Qualification, and Validation services for the life science industry. Our team consists of seasoned experts in the validation of facilities, utilities, equipment, computer systems, processes, cleaning, and test methods. We provide end to end solutions with expertise in Project Planning, CQV Master Planning, Requirement Specifications, Risk Assessments, Commissioning, Decommissioning, FATs, SATs, Installation Qualifications, Operational Qualifications, Performance Qualifications, Summary Reports, Traceability Matrixes, Calibration, Temperature/Humidity Mapping Services and more.

Our consultants have access to our global Subject Matter Experts and training materials 24/7, and guarantee quality when delivering your projects. Our team of professionals can support your company in the full CQV lifecycle. We facilitate a timely and cost-effective solution curated to your company. By outsourcing your CQV needs, you’re able to focus on other aspects of your company while also accelerating your business. While working with PSC, your organization will gain insightful knowledge to continuously grow your company. 

 

Our Expertise

  • Facilities Equipment
  • Utilities Equipment
  • Processes
  • Cleaning Validation
  • Test Method Validation
  • Greenfield CQV Projects
  • New Production Suite Commissioning
  • Decommissioning 

 

 

 

 

End-to-End Solutions

  • Project Planning
  • Validation Master Plans (VMP)
  • User Requirements Specifications (URS)
  • Risk Assessments
  • Protocols
  • FAT
  • SAT
  • Summary Reports
  • Traceability Matrixes
  • Calibration Matrix
  • SOPs
  • Integrated Commissioning and Qualification (ICQ) 

 

  • Validation Protocol Format
  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ) 
  • Good Automated Manufacturing Practice (GAMP)
  • Current Good Manufacturing Practice (cGMP) Review
  • Continued Process Verification (CPV)
  • Pre-Operational Verifications 
  • Commissioning and Startup
  • Technical Audits and Due Diligene 

An Example Project we Have Completed in the Past: Equipment Validation and Qualification of chambers, autoclaves, tunnels, lyophilizers, packaging, shipping, related process equipment, and associated document generation and revision.

 

Download Our CQV White-Paper

What Our Clients are Saying

“During the past year, our company has been working with PSC on various activities within the development and implementation of a new medical device product. PSC offers high quality services, and we can say that we have always been satisfied by their work.”

“The skillsets that PSC provides in regulatory support helped us overcome a large obstacle in particular. The regulatory support that we had from PSC was very independent and if we had an issue, PSC consultants were willing to work cross-functionally to meet our needs. No micromanaging required. Great communication. Minimal supervision. I don’t think we would have been as successful without them. The expertise and the connections we’ve created with PSC are beyond our expectations. I’ve never had that relationship with a company like I’ve had with PSC. Just phenomenal! It made my life easier.”

“This is to certify that PSC Biotech® (PSC) has done a good job for our company in the range of auditing and consultancy. Their work was remarkably distinguished as auditors. As consultants, their work was successfully handled and enabled based on the level of expertise of their team in the U.S. and abroad.”

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, and Validation (CQV) services for one of the clients plants since the mid 1990’s to the present.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

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